Bluetooth blood pressure monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 6, 2018 Shenzhen Kingyield Technology Co., Ltd. Dacheng Gong General Manager Section C2, Fuhai Industrial Zone, Fuyong Town, Baoan District Shenzhen, 518000 Cn Re: K182018 Trade/Device Name: Bluetooth Blood Pressure Monitor, BPW1 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 5, 2018 Received: September 6, 2018 Dear Dacheng Gong: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Image /page/1/Picture/6 description: The image contains the text "Shawn W. Forrest -A". The text is arranged in two lines, with "Shawn W." on the first line and "Forrest -A" on the second line. The font is a simple, sans-serif typeface, and the text is black against a white background. There is a light blue design in the background. 12 19200300 100 1 1=130040 for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182018 Device Name Bluetooth Blood Pressure Monitor, BPW1 #### Indications for Use (Describe) This blood pressure monitor is intended to be used to measure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heasurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| | | Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary Date the summary was prepared: September/05/2018 #### I. Administrative Information ## 1.1 Submitter/Owner Name: Shenzhen Kingyield Technology Co., Ltd. Address: Section C2, Fuhai Industrial Zone, Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Facility registration number: 3007420856 #### 1.2 Contact person Authorized Contact Person: Dacheng Gong Position: General Manager Address: Section C2, Fuhai Industrial Zone, Fuyong Town, Baoan District, Shenzhen, 518103, China Tel: 86 755 2737 1997 Fax: 86 755 2733 1856 Email: kingyield@kingyield.com #### II. MODIFIED DEVICE Device type by its common name: Bluetooth Blood Pressure Monitor, BPW1 Regulation Number: 21CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II Panel: Cardiovascular Product Code: DXN #### III. PREDICATE/UNMODIFIED DEVICE Device Name: BP210 Wrist Blood Pressure Monitor Common/Usual Name: Wrist Blood Pressure Monitor BP210 510(k) Number: K112042 510(k) submitter/holder: Shenzhen Kingyield Technology Co., Ltd. ## IV. MODIFIED DEVICE DESCRIPTION Bluetooth Blood Pressure Monitor, BPW1 is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method, including irregular heartbeats (IHB) from the wrist. The device is powered by a rechargeable Lithium battery. The device has an START/STOP button for starting the measurement and stopping the measurement at any time when measuring. The MEM button is for displaying the last measurement. The device can also connect the mobile platform with an MMA (mobile medical application) as its accessory which can start/stop the device through Bluetooth 4.0. {4}------------------------------------------------ An irregular heartbeats rhythm is defined as a rhythm that varies by 25% less or more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure. ## V. INDICATIONS FOR USE This blood pressure monitor is intended to be used to measure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm. ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE/UNMODIFIED DEVICE | Comparison<br>item | Predicate/unmodified<br>device | Modified device | Explanation of the<br>differences | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The trade name | BP210 Wrist Blood<br>Pressure Monitor | Bluetooth blood pressure<br>monitor, BPW1 | | | 510(k) Number | K112042 | | | | Applicant | Shenzhen Kingyield<br>technology Co., Ltd. | Shenzhen Kingyield<br>technology Co., Ltd. | Identical | | Recommended<br>classification<br>regulation | 21CFR 870.1130,<br>Noninvasive Blood<br>Pressure Measurement<br>System | 21CFR 870.1130,<br>Noninvasive Blood Pressure<br>Measurement System | Identical | | Regulatory<br>Class | II | II | Identical | | Panel | Cardiovascular | Cardiovascular | Identical | | Product Code | DXN | DXN | Identical | | Intended use | BP210 Wrist Blood<br>Pressure Monitor is<br>intended to be used to<br>measure blood pressure<br>(systolic and diastolic)<br>and heart rate from the<br>wrist by using the<br>oscillometric method.<br>The device is intended | This blood pressure monitor is<br>intended to be used to measure<br>blood pressure (systolic and<br>diastolic) and heart rate from<br>the wrist by using the<br>oscillometric method. The<br>device detects the appearance<br>of irregular heartbeats during<br>measurement and gives a | Identical<br>though the wording is<br>adjusted | | | | | | | | population, not applied<br>to the other populations<br>such as neonatal baby.<br>It can't be used while<br>the wrist (arm) has<br>bleeding or wound to<br>avoid the blood flowing<br>from the wound in<br>pressurizing.<br>The wrist circumference<br>is limited to 13.5cm -<br>21.5cm. | The device is intended for<br>using in only adult population,<br>not applied to the other<br>populations such as neonatal<br>baby. It can't be used while the<br>wrist (arm) has bleeding or<br>wound to avoid the blood<br>flowing from the wound in<br>pressurizing. The wrist<br>circumference is limited to<br>13.5cm - 21.5cm. | | | Measuring<br>principle | Oscillometric method | Oscillometric method | Identical | | Measuring<br>range | Cuff pressure: 0~299<br>mmHg Pulse : 40~180<br>beat/min | Cuff pressure: 0~299 mmHg<br>Pulse : 40~180 beat/min | Identical | | Max cuff<br>pressure | 300mmHg | 300mmHg | Identical | | Accuracy | Static Pressure: ± 3mmHg<br>Pulse: ± 5% reading value | Static Pressure: ± 3mmHg<br>Pulse: ± 5% reading value | Identical | | Inflation | By air pump | By air pump | Identical | | Deflation | Not Apply | Not apply | Identical | | Pressure release | By automatic valve | By automatic valve | Identical | | Dimensional<br>Specifications | Body: 77*62*34<br>Body with cuff: 77*62*84 | Body: 41*47*17.7<br>Body with bladder &<br>wristband: 270.12*41*17.7 | Equivalent<br>The changes are tested<br>according to the<br>requirements of the<br>standards IEC 60601-1, IEC<br>60601-1-2, IEC 62133, EN<br>1060-3,<br>IEC 80601-2-30,<br>60601-1-11, EN 300 328,<br>EN 301 489-1, EN 301<br>489-17, FCC 47 CFR Part<br>15, Subpart B & FCC 47<br>CFR Part 15 Subpart C, IEC<br>62366-1, IEC 60601-1-6,<br>and ISO81060-2.<br>The changes in dimensional<br>specifications are | | | | | | | Bladder and<br>Cuff | Cuff containing bladder | Bladder + wristband | documented; do not affect<br>the intended use or the<br>fundamental scientific<br>technology.<br><br>Equivalent<br>The changes are tested<br>according to the<br>requirements IS081060-<br>2:2013, ISO 10993-1, ISO<br>10993-5, and ISO 10993-10.<br><br>The changes in the<br>specifications are<br>documented; do not affect<br>the intended use or the<br>fundamental scientific<br>technology. | | Event marking | By pressing the<br>START/STOP button | By pressing the<br>START/STOP button;<br>By click "START/STOP" on<br>APP | Equivalent<br>The change in the<br>specification is documented,<br>the cybersecurity risk has<br>been considered and the<br>overall residual risk is<br>acceptable.<br>The change does not affect<br>the intended use or the<br>fundamental scientific<br>technology. | | | By pressing the MEM<br>button | By pressing the MEM button | Equivalent | | Display | Device LCD | Device LCD;<br>LCD on collateral device<br>while connecting | Equivalent<br>The changes of the user<br>interface are documented,<br>do not affect the intended<br>use or the fundamental<br>scientific technology.. | | Operating<br>Temp. &<br>humidity | Temp.: 10~40°C<br>Humidity: 15~90%RH<br>(noncondensing )<br>Atmospheric:<br>105kPa~80kPa | Temp.: 10~40°C Humidity:<br>15~90%RH (noncondensing )<br>Atmospheric: 106kPa~80kPa | Equivalent<br>The environmental<br>conditions changes are<br>tested according to the<br>requirements of the<br>standards IEC 60601-2-30 | | | | | | | Storage Temp.<br>& humidity | Temp.: -20~55°C<br>Humidity: 10~90%RH<br>(noncondensing ) | Temp.: -20~55°C Humidity:<br>0~95%RH (noncondensing ) | Equivalent<br>The environmental<br>conditions changes are<br>tested according to the<br>requirements of the<br>standards IEC 80601-2-30<br>and IEC 60601-1-11. These<br>changes do not affect the<br>intended use. | | Communication | USB cable---<br>The memory data can be<br>transferred to the PC by<br>connecting the device with<br>the PC via USB cable | Bluetooth | Equivalent<br>The changes are tested<br>according to the<br>requirements of the<br>standards IEC 80601-2-30<br>and 60601-1-11.<br><br>The changes in the<br>specifications are<br>documented; do not affect<br>the intended use or the<br>fundamental scientific<br>technology. | | IHB function | IHB function | IHB function | Identical | | Memory<br>function | 90*2 | 30 | Equivalent<br>The change in the<br>specification is documented<br>and tested, does not affect<br>the intended use or the<br>fundamental scientific<br>technology. | | Automatic<br>power-off | In 2 minutes | No automatic power-off<br>function, adding clock<br>function instead. | Equivalent<br>The change in the<br>specification is documented<br>and tested, does not affect<br>the intended use or the<br>fundamental scientific<br>technology. | | Clock function | No clock | Yes | Equivalent | | Material | PC and ABS for the case<br>and plastic foil for the<br>labels of the device.<br>Biocompatible materials<br>are used for the applied<br>parts (Cuff containing<br>bladder). | Zinc alloy for the case of the<br>device and ABS for Button.<br>Biocompatible materials are<br>used for the applied parts<br>(Bladder + wristband). | specification is documented<br>and tested, does not affect<br>the intended use or the<br>fundamental scientific<br>technology. | | Energy source | AAA alkaline battery x 2<br>pcs | Li-ion Rechargeable battery<br>with 250 charging cycles | Equivalent<br>The change in the<br>specification is documented<br>and tested, does not affect<br>the intended use or the<br>fundamental scientific<br>technology. | | Sterilization | Not applicable | Not applicable | Identical | | Expiration date | Not applicable | The rechargeable battery<br>installed in the device will<br>self-discharge | Equivalent<br>Instruction Manual is<br>revised to add "The device's<br>battery should be recharged<br>periodically, even during<br>storage since the<br>rechargeable battery<br>installed in the device will<br>self-discharge, leading to an<br>unacceptably low voltage,<br>thus damaging the battery."<br>The change in the<br>specification is documented,<br>does not affect the intended<br>use or the fundamental<br>scientific technology. | | Accessories | Instruction manual | Instruction manual which is<br>revised according to the<br>changes made | Equivalent<br>The change in the<br>specification is documented,<br>does not affect the intended<br>use or the fundamental<br>scientific technology. | | | Soft rule | Equivalent | | | | | The adding of the soft rule<br>that increases the measuring<br>accuracy of the device is<br>documented | | | BP-management software<br>on Personal Computer | A mobile medical app on<br>Android | Equivalent<br>The change in the<br>specification is documented,<br>the cybersecurity risk has<br>been considered and the<br>overall residual risk is<br>acceptable.<br>The change does not affect<br>the intended use or the<br>fundamental scientific<br>technology. | | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ## VII.PERFORMANCE DATA ## VII.I Performance Testing - Bench Testing information demonstrating safety and effectiveness of the intended environment of use is supported by testing that was conducted. The following testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate devices. The following National and International Standards were utilized for testing the subject device. #### a. EMC Test: - IEC 60601-1-2: 2014 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests ## b. Safety Test: -IEC 60601-1:2005+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance -IEC 60601-1-11:2015, Medical electrical equipment-Part 1-11: General Requirement for basic safety and essential performance - Collateral Standard: Requirements for medical electrical systems used in the home healthcare Environment -IEC 62133:2012, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications {10}------------------------------------------------ ### c. Reliability Test: -IEC 80601-2-30:2009+A1:2013 Medical electrical equipment-Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers, 2013 -EN 1060-3: 1995+A2:2009 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems ### d. Radio Frequency Wireless Test: -EN 300 328 V2.1.1, Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU -Draft EN 301 489-1 V2.2.0, ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU and the essential requirements of article 6 of Directive 2014/30/EU -Draft EN 301 489-17 V3.2.0, ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for Broadband Data Transmission Systems; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU ### e. FCC Test: -FCC 47 CFR Part 15, Subpart B -FCC 47 CFR Part 15, Subpart C -FCC 47 CFR Part 1.1307 -FCC 47 CFR Part 2.1093 #### f. Biocompatibility Test: -ISO 10993-1:2009, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process -ISO 10993-5:2009, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity -ISO 10993-10:2010, Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Bluetooth Blood Pressure Monitor, BPW1 tested met all relevant requirements of the aforementioned tests. The evaluation of these results present no new issues related to safety or effectiveness of the testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate devices. The test methods used are the same as those submitted in the original submission. VII-II Performance Testing – Animal N/A {11}------------------------------------------------ # VII-III Performance Testing - Clinical ## Clinical Validation: - ISO81060-2:2013 Non-invasive sphygmomanometers —Part 2: Clinical validation of automated measurement type The device has achieved the requirements of ISO18060-2:2013. ## VII-IV Cybersecurity Risk Management - FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2014) - FDA Post Market Management of Cybersecurity in Medical Devices (2016) The overall residual risk posed by the medical device is acceptable using the criteria defined in the risk management plan. #### VIII. SUBSTANTIAL EQUIVALENCE CONCLUSION The modified device has been found to be substantially equivalent to the predicate/unmodified device. Differences between the modified device and the predicate/unmodified device do not raise new questions of safety or effectiveness.